CCC Audit for CROs

The Problem for Companies engaged in Sponsoring Projects and related activities is that their core competency, knowledge, and experience is in their particular technical field. In order to manage the data from those Projects, a Sponsor may contract for the services using a Contract Research Organization, a CRO, that has the resources and the necessary personnel, training and experience to properly provide data management and monitoring services. Because the core competency of the Sponsor is not in data base design, management and administration, that Sponsor is exposed to risk.

This Risk is that the CRO it has contracted with may have certain weaknesses, problem areas or misrepresentations that render the Sponsor vulnerable to a breakdown in the data management area. This breakdown can be not only very costly, but also expose the Sponsor to failures in data management area that could cause serious delays and possible failure of the Project.

The Solution to Significantly Reducing this Risk is for a Capability, Competency and Compliance Audit. A CCC Audit of the CRO retained by the Sponsor for data management is an independent outside review of the organization responsible for the data management of the Project, and provides a Sponsor with additional assurance that problems in the data management process will not jeopardize the Project and that the CRO has the capabilities they say they do.

The CCC Audit is a unique process developed by WNY Data Management Services that provides a Sponsor with a separate, independent audit of the CRO that is engaged in providing data management services for the Project. It utilizes the knowledge and experience of WNY Data Management Services in the Data Base Management Industry to design a specific audit process for the specific application of data management service for the Project.

A CCC Audit consists of

1. Capability - An in depth assessment of the resources of the CRO engaged on the Clinical Trial to determine that these resources are adequate to support the data management process.
2. Competency – A review and validation of the credentials of the CRO to ascertain that they have the technical and industry expertise to perform the services they have contracted to provide.
3. Compliance – A review and validation of the CRO to ascertain that they are in compliance with all regulatory requirements for operations of data management of the Project.

In addition, if problem areas are found the CCC Audit will provide a Risk Assessment of the CRO – an analysis of areas of potential future problems and recommendations for oversight by the Sponsor to prevent those problems from occurring.

The CCC Audit Can Take Place at any time in the process of the Project. As with any preventive action, the earlier the CCC Audit takes place the greater the benefit.

The Value of a CCC Audit is that while it cannot provide a 100% guarantee against future problems with the CRO, it can substantially reduce the likelihood of those problems occurring. In addition, in the event of an audit by a Regulatory Agency, the CCC Audit is a strong indication that the Sponsor has undertaken due diligence of its CRO and this increases the likelihood that the Sponsor will pass a regulatory audit.

The Cost of a CCC Audit will be very small in comparison to the overall cost of the Project, usually in the range of $5,000 to $15,000 depending upon the size of the Project and the scope required for the CCC Audit. A firm Proposal with a fixed cost is provided prior to any obligation on the part of the Sponsor requesting the CCC Audit.

To Learn More About a CCC Audit and To Determine if it is Appropriate for your Project, contact WNY Data Management Service, Inc. for a free consultation.